Trial Outcomes & Findings for Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) (NCT NCT02101983)

Results Overview

To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

3 months

Results posted on

2018-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Outpatient HiDAC Consolidation Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Overall Study STARTED	5	6
Overall Study COMPLETED	4	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Outpatient HiDAC Consolidation Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Overall Study Physician Decision	1	0

Baseline Characteristics

Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Outpatient HiDAC Consolidation n=5 Participants Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group n=6 Participants Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Subjects with a documented unequivocal diagnosis of AML in complete remission, age \>/= 55 years, with good performance status and adequate renal and hepatic function. Subjects who are eligible for standard of care inpatient HiDAC consolidation will be approached to participate in the Quality of Life comparison group.

To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.

Outcome measures

Outcome measures
Measure	Outpatient HiDAC Consolidation n=4 Participants Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group n=5 Participants Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Subjects must have an unequivocal diagnosis of AML in a documented complete remission, age \>/= 55 years with a good performance status and adequate renal and hepatic function. Subjects who decline participation as an outpatient will be approached to participate in the quality of life comparison group.

Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.

Outcome measures

Outcome measures
Measure	Outpatient HiDAC Consolidation n=4 Participants Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group n=5 Participants Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Number of Participants Who Successfully Completed the of Quality of Life Form	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Data was not collected from the participants for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Outpatient HiDAC Consolidation

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Quality of Life Comparison Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Outpatient HiDAC Consolidation n=4 participants at risk Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group n=6 participants at risk Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Blood and lymphatic system disorders neutropenia	25.0% 1/4	0.00% 0/6

Other adverse events

Other adverse events
Measure	Outpatient HiDAC Consolidation n=4 participants at risk Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle. Cytosine Arabinoside	Quality of Life Comparison Group n=6 participants at risk Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy. Cytosine Arabinoside
Vascular disorders facial flushing	25.0% 1/4	0.00% 0/6
Musculoskeletal and connective tissue disorders increased creatinine	25.0% 1/4	0.00% 0/6
Hepatobiliary disorders increased alanine aminotransferase	25.0% 1/4	0.00% 0/6

Additional Information

Deborah Mulford

University of Rochester

Phone: 585-275-5823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place